Ten23 health is a human-centric and sustainable strategic partner of choice for the pharmaceutical industry and biotech start-ups for the development, manufacture, and testing of tomorrow’s medicines. We support our clients in developing differentiated, stable, usable, and safe injectable treatments for patients.
About the Role
We are looking for a highly skilled Senior Engineer Pharma Operations Engineering Fill & Finish to join our Technology & Capability Expansion team in Visp. This newly defined, critical role will serve as the technical authority ensuring the successful transition of our new fill-and-finish facility, Viva 2, from the project phase into stable, routine GMP operations.
Responsibilities
* Act as the single accountable technical authority for fill-and-finish systems (filling lines, isolators, freeze dryers, inspection, and packaging), ensuring their reliable and compliant startup and ramp-up.
* Drive the seamless integration of CAPEX projects into active operations, overseeing qualification, validation, and the final handover process.
* Establish robust technical systems that guarantee efficient maintenance and performance optimization, driving standardization, digitalization, and continuous improvement.
* Lead projects within a matrix structure, coordinating strongly across Production, QA, CQV, Warehouse, Tech Support, MSAT, and QC Monitoring to effectively manage deviations, CAPAs, and change controls.
* Ensure all operations, systems, and equipment are fully inspection‑ready and maintain strict regulatory compliance aligned with EU GMP Annex 1 and other global standards.
Qualifications
* Degree in Engineering, Pharmaceutical Technology, Biotechnology, or a related technical field.
* Extensive, proven experience in Pharma Operations Engineering, specifically focusing on aseptic Fill & Finish processes and complex equipment (isolators, filling lines, freeze dryers).
* Strong background in technical project management and operational readiness, with a proven track record of transitioning facilities or large‑scale CAPEX projects into routine GMP operations.
* Deep understanding of global regulatory standards, with specific expertise in EU GMP Annex 1.
* Demonstrated ability to manage complex deviations, implement CAPAs, and navigate change‑control processes within a highly regulated environment.
* Excellent cross‑functional coordination and communication skills, capable of influencing and leading within a matrix organization without direct reporting lines.
Benefits
We offer a dynamic environment where you can contribute meaningfully, collaborate with exceptional minds, and unlock your full potential.
For more information and clarification, please connect Amrith (amrith.kiran@ten23.health) from our Talent team!
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